I've had three distinct careers: biomedical scientist; FDA drug regulator; and scholar at the Hoover Institution, a think-tank at Stanford University. During the first of these, I worked on various aspects of gene expression and regulation in viruses and mammalian cells. I was the co-discoverer of a critical enzyme in the influenza (flu) virus. While at the FDA, I was the medical reviewer for the first genetically engineered drugs and thus instrumental in the rapid licensing of human insulin and human growth hormone. Thereafter, I was a special assistant to the FDA commissioner and the founding director of the FDA's Office of Biotechnology. Since coming to the Hoover Institution, I have become well known for both contributions to peer-reviewed scholarly journals and for articles and books that make science, medicine, and technology accessible to non-experts. I have written four books and about 2,000 articles. I appear regularly on various nationally syndicated radio programs. My most frequent topics include genetic engineering, pharmaceutical development, and the debunking of various manifestions of junk science.

11/30/2011 @ 10:53AM1,392 views

Solyndra And Siga Sagas A New Low In Obama's Crony Capitalism

In November 1973, President Richard Nixon famously told a meeting of editors that “people have got to know whether or not their president is a crook. Well, I’m not a crook.” It turned out, of course, that he was a crook; in fact, a bigger crook than we were to learn for many years. It was more than three decades until we found out, for example, that the presidential pardon he granted to Teamster thug Jimmy Hoffa was bought by at least two bags of cash delivered directly to Nixon’s attorney general, John Mitchell (according to the Teamsters/Mafia goon who dropped them off at Mitchell’s home).

Barack Obama isn’t keeping us in suspense; we’re learning in a much shorter time frame about the flagrant dishonesty and corruption of his administration. There’s one major difference: As repugnant as Nixon’s malfeasance was, the Watergate and Hoffa scandals didn’t cost the taxpayers anything (at least, until the investigations and prosecutions began). That can’t be said for Obama.

Solyndra, a California-based company that made solar panels, is Exhibit No.1. In spite of widespread predictions that Solyndra was not viable because of recurring losses, cash flow problems and a decreasing worldwide market for the company’s products, the White House pushed hard to give Solyndra huge infusions of cash because Obama buddy, campaign contributor and frequent White House visitor George Kaiser owned an equity firm that backed the company.

Solyndra did go belly-up, of course — after delaying the announcement of massive layoffs until after the 2010 election, at the specific request of administration officials. And due to the actions of Obama and his Energy Secretary, Steven Chu, the taxpayers are unlikely to see a penny of the $528 million they put into Solyndra, thanks to a highly unusual aspect of the deal that put private creditors’ interests ahead of those of the government.

Exhibit No. 2 pertains to a company called Siga, whose flagship product is a drug to treat smallpox. The Los Angeles Times’ headline and sub-headline summarize the story nicely: “Cost, need questioned in $433-million smallpox drug deal; a company controlled by a longtime political donor gets a no-bid contract to supply an experimental remedy for a threat that may not exist.”

Medically and epidemiologically, smallpox is one of the most feared and potentially devastating of all infectious agents. It spreads from person to person, primarily via droplets coughed up by infected people, via direct contact and from contaminated clothing and bed linens. Smallpox is fatal in about a third of previously unvaccinated people who contract the disease.

If the re-emergence of smallpox were likely, widespread vaccination (rather than stockpiling a treatment) would be appropriate. However, smallpox virus no longer occurs in nature – the last naturally occurring case was in 1977 – but is only known to exist in two legitimate repositories, one in the U.S., the other in Russia. It is very difficult to obtain, cultivate and disseminate.

Siga was given the contract for 1.7 million doses of the drug, called ST-246, for about $255 per dose, well above the $170 that government contract specialists had considered fair and reasonable. (By contrast, the vaccine costs about $3 a dose.)

Siga was offered the contract on a “sole source” procurement basis – meaning that no other company was asked to bid.

When government contracting specialists balked at both the huge markup permitted to the company and the sole-source arrangement, a political appointee, Assistant Secretary of Health and Human Services Nicole Lurie, replaced the lead negotiator.

But there’s more. The U.S. biodefense stockpile contains 300 million doses of smallpox vaccine, enough for every eligible man, woman and child. An anti-viral drug would be needed only for people who were exposed to the smallpox virus but couldn’t get the vaccine within four days of exposure.

There’s also a problem with testing such a drug: For ethical reasons, it can’t be tested for efficacy — you can’t expose people to a lethal virus purposely in a clinical trial — so there’s no guarantee that the drug will work. And that creates yet another wrinkle: In the absence of a verified imminent threat, the FDA is unlikely to approve such a product without proof of its efficacy. An FDA official admitted there is “no clear regulatory path” to the approval of such drugs. DHHS officials were well aware of this glitch.

It is hard to find anyone outside the government and Siga who thinks stockpiling ST-246 is a good idea. Dr. Thomas M. Mack, an epidemiologist at USC’s Keck School of Medicine, who was involved in controlling smallpox outbreaks in Pakistan and has advised the FDA about the virus, called the proposed stockpiling “a waste of time and a waste of money.”

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